MEXICO CITY, May 12, 2026 — PSI CRO has opened a new office in Mexico City at Av. Insurgentes Sur 1458, Actipan, Benito Juárez, building on more than a decade of clinical trial work in the country. For sponsors, the office provides direct access to a local, multidisciplinary team with on-the-ground expertise. For PSI staff, it will serve as a central hub that improves coordination, speeds decision-making, and strengthens collaboration with sites and regulators across one of Latin America’s key clinical research markets.
Mexico ranks as Latin America’s second-largest clinical trial market, supported by a population of 130 million with documented genetic diversity – a profile relevant to sponsors developing precision medicine and targeted therapy programs.i The national regulatory framework, governed by COFEPRIS (Federal Commission for Protection against Sanitary Risks) and aligned with ICH standards, provides a predictable pathway for pivotal study submissions. Mexico has also committed to increasing annual clinical research investment from $200 million to $2 billion by 2030, a trajectory that reflects growing alignment between national health priorities and global development timelines.ii
For sponsors running multi-site and cross-border studies, these factors translate into predictable timelines, faster patient enrollment, and reliable data quality. The PSI Mexico City team brings together expertise in clinical operations, feasibility, regulatory affairs, start-up, medical monitoring, logistics, and site management. It is equipped to support pivotal trials across PSI's core therapeutic areas, including oncology, infectious disease, gastroenterology, immunology, and rare diseases.
"Mexico has consistently ranked among the top five highest-enrolling countries in PSI pivotal studies across oncology and other indications," said Oscar Podesta, Head of Latin America, PSI. "That performance reflects both the quality of the sites we work with and the depth of our local relationships built over more than a decade. Sponsors need a partner with local knowledge and the ability to manage complex trials day to day. This office strengthens our ability to do that.”
The opening reflects PSI’s continued global growth, with a focus on predictable operational delivery in complex pivotal studies.
PSI CRO is a global full-service contract research organization (CRO), committed to being the best CRO in the world as measured by its employees, customers, investigators, and vendors. PSI's key operational differentiator is predictable on-time delivery of clinical trials. This metric remained above 90% in 2025.
The company specializes in pivotal phase 2 and phase 3 clinical trials in oncology, hematology, gastroenterology, immunology, infectious diseases, neuroscience, and other indications. PSI provides expertise in complex trials at the forefront of precision medicine, including platform and umbrella designs, trials in targeted immunotherapy, radiopharmaceuticals, and cell and gene therapies.
In 2025, PSI celebrated its 30th year of business as the only fully independent and privately owned mid-sized CRO. PSI employs over 3,300 people across 58 countries as of March 31st , 2026.
[1] Haynes L. Mexico: Towards a Clinical Trials Powerhouse. PharmaBoardroom. 2025. Accessed May 2026. Available from: https://pharmaboardroom.com/articles/mexico-towards-a-clinical-trials-powerhouse/
[1] Bensilum J. Can regulatory reform unearth LATAM's untapped potential for drug development? Clinical Trials Arena. 2025. Accessed May 2026. Available from: https://www.clinicaltrialsarena.com/news/can-regulatory-reform-unearth-latams-untapped-potential-for-drug-development/
